Occlusive vascular disease is a common ailment in people resulting in enormous costs to the health care system. Blood clots are the most common type of occlusion. Removal of clots from the body has been studied for several years and many techniques (devices and methods) have been studied and practiced. One of the more common techniques is one referred to as embolectomy. Embolectomy is a treatment whereby the clot is removed from the body as opposed to being dissolved and then reabsorbed. Another alternative is thrombolysis. As the name indicates, this is lysing (eating) of the thrombus (blood clot). Usually this requires a significant amount of potentially dangerous and always expensive drug that is injected into the vasculature. The drug delivery is sometimes aided with special catheters, which may increase efficacy, but certainly increase cost. The deposit of sinuous plaque (arteriosclerosis) to the inner wall of arteries usually precedes clot formation. Several expensive devices (dilatation balloons, stents, mechanical cutters, etc.) have been introduced to fight this vascular occlusive disease, but none of which has proven to be the `magic bullet` to treat this ubiquitous disease. Because of the various problems with all of the techniques and approaches to solving this medical condition, there exists no particular method or device that is considered the most accepted mode of treatment.
Unfortunately, cancer too is a common ailment resulting in over 1,500 deaths every day in the U.S. (550,000 every year). Therapy modalities for cancer are plentiful and continued to be researched with vigor. Still, the preferred treatment continues to be physical removal of the cancer. When applicable, surgical removal is preferred (breast, colon, brain, lung, kidney, etc.). Surgical removal is often extremely invasive and efforts to remove cancerous tissue in a less invasive way continue, but have not yet been perfected. The only cure for cancer continues to be early diagnosis and subsequent early treatment. As cancer therapies continue at an earlier stage of diagnosis, the cancerous tissue is smaller and smaller. Early removal of these smaller cancers demand new techniques for removal and obliteration that are less invasive. The instant invention describes new devices for less invasive cancer therapy. There are many techniques and devices known in the art for removing blockages in the vascular system and other passageways of the human body as well as removing other diseased tissue.
There is a continuing need for improved devices to meet at least the following objectives.
The first objective is to reduce cost. This is particularly important in recent years where it is clear for safety and sanitary reasons that these will be single use devices. A device, even though it performs a function in some improved manner, will not be widely used if it is considerably more costly than the alternatives available.
A second objective is to provide a device that is simple to use and in a very real sense simple to understand. This will encourage its adoption and use by medical personnel. It will also tend to keep cost low.
The third objective is to provide a device that entails a procedure with which the medical profession is familiar so that the skills that have been learned from previous experience will continue to have applicability.
A fourth objective relates to the effectiveness and thoroughness with which the biological tissue or foreign body is removed. With regard to biological tissue removal, it is important that an optimum amount of the mater be removed; recognizing that no device is likely to provide one hundred percent optimization.
A fifth objective concerns safety, a matter which is often so critical as to trump the other considerations. It is important to avoid unnecessary tissue trauma. In the case of using the present invention or its similar inventions in the tubular channels of the body, it is critically important to avoid breaking up matter in a fashion that leads to flushing elements of the blockage throughout the body involved. The same may be true for removal of diseased tissue removal, certainly in the case of removal of cancerous tissue.
There are trade-offs in design considerations to achieve the above five interrelated objectives. Extreme simplicity and a very simple procedure might overly compromise safety. Addressing all of these considerations calls for some trade-off between the objectives.
Accordingly, a major object of this invention is to provide an improved removal device that achieves the objectives of reduced cost, enhanced simplicity, a standard procedure, high effectiveness and a high degree of safety. Most particularly, it is an object of this invention to achieve these objectives with an enhanced trade-off value for the combined objectives.
For these reasons, it is desirable to provide an improved device that may circumvent some of the problems associated with previous techniques. This improved medical device provides a new configuration that will eliminate some of those problems and methods for their use, which facilitate removal of vascular obstructions in the operating room or interventional suite.